NCT00412061

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.

Conditions

• Carcinoid Tumor
• Malignant Carcinoid Syndrome

Interventions

Type	Name	Description
DRUG	Octreotide	Octreotide 30 mg intramuscularly (i.m.) every 28 days.
DRUG	Placebo	A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
DRUG	Everolimus	A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-04-01
• Completion: 2013-06-01
• First posted: 2006-12-15
• Last updated: 2014-11-21
• Results posted: 2012-03-12

Locations

70 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Italy, Netherlands, Slovakia, Spain, Sweden, United Kingdom